Method for controlling position of medical instruments

ABSTRACT

A method for guiding an instrument associated with a medical device, such as an endoscope, is provided. The method is useful for positioning a flexible medical instrument extending from an instrument channel of an endoscope, such as for the treatment of tissue. The method is also useful for providing cooperative motion between first and second instruments extending from instrument channels within a patient&#39;s body lumen. In one embodiment, the step of guiding the instrument comprises bending the instrument as the instrument extends from the instrument channel.

[0001] This application is related to the following copending,concurrently filed patent applications: application Ser. No. ______“Apparatus for Guiding an Instrument Used with an Endoscope”[AttorneyDocket No. END 779]; and application Ser. No. ______ “Biopsy ForcepsDevice and Method” [Attorney Docket No. END 839] which are hearbyincorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to use of medical instruments, ingeneral, and, more particularly, to a method for guiding the position ofa medical instrument used with a medical device such as an endoscope.

BACKGROUND OF THE INVENTION

[0003] Physicians have often used endoscopes to examine, to biopsy, andto ablate the tissue of patients within lumens such as the esophageousand the bowel. These procedures include esophageal duodenoscopy, (EGD),colonoscopy, and polypectomy. Endoscopes used in these procedures can beseveral feet long and generally comprise one or more instrument channelsand optical fiber bundles. The instrument channels and optical fiberbundles open into the body at the distal end of the endoscope and aregenerally parallel to the axis of the flexible endoscope. Physiciansplace flexible instruments through the instrument channels whilevisualizing and illuminating a site using the optical fiber bundles. Theinstruments have end-effectors at the distal end for performing usefultherapeutic work to tissue. The instruments also provide at theirproximal ends operating mechanisms for actuating the end-effectors. Suchinstruments placed through an instrument channel of an endoscope mayinclude biopsy forceps for tissue sampling, electrical wires forradiofrequency ablation, or tubes used for irrigation, gas transfer,particular matter transfer, and suction.

[0004] A physician performing a therapeutic procedure with the use of anendoscope places a long, flexible instrument through the endoscope'sinstrument channel and then positions the instrument near the sitewithin the body lumen where a therapeutic procedure is to be performed.The physician grasps the endoscope with one hand and introduces theflexible instrument from an entrance at the proximal end of theendoscope with the other. An assistant usually holds the proximal end ofthe flexible instrument and operates the mechanism at the proximal endof the instrument to actuate the end-effector.

[0005] Locating the end-effector within the lumen presents difficultiesto the physician. The flexible instrument emerges from the instrumentchannel of the endoscope in a direction parallel to the axis of theendoscope. Many times work needs to be performed by the instrument atthe inner wall of a body lumen, and at an angle to the axis of theendoscope. Much tedious maneuvering of both endoscope and instrument isneeded to place the end-effector into a position to perform useful work.The flexible nature of the instrument creates difficulties in locatingthe end-effector at the needed position on the inner wall of the bodylumen. Rotating the endoscope to accommodate the instrument causes theimage on the monitor to rotate creating visualization difficulties forthe physician.

[0006] When the task to be performed is a biopsy, a tissue sample orspecimen must be transported away from the work site for collection. Tocollect the specimen, the physician pulls the entire instrument from theendoscope, removes the specimen, places the specimen into a collectionjar, and replaces the instrument into the endoscope. The physician mustthen manipulate the instrument into a new position to take anotherspecimen.

SUMMARY OF THE INVENTION

[0007] Applicants have recognized the need for a method and apparatusfor facilitating manipulation of surgical instruments at the distal endof a medical device, such as an endoscope. In one embodiment, thepresent invention comprises a method of treating tissue within apatient, the method comprising the steps of providing at least oneinstrument having a distal end; providing at least one channel foraccessing a treatment site; extending at least a portion of theinstrument from a distal end of the channel to access the treatmentsite; and guiding motion of the distal end of instrument at thetreatment site. The step of guiding the motion of the distal end of theinstrument can comprise restricting twisting of the instrument about itslongitudinal axis, while bending the instrument to access a tissue siteon a lumen wall.

[0008] The method can also provide cooperation between two or moreflexible instruments extending from channels in a medical device, suchas an endoscope. According to one embodiment of the invention, themethod can comprise the steps of: providing a first instrument having adistal end; providing a second instrument having a distal end; providinga first channel for accessing a treatment site; providing a secondchannel for accessing a treatment site; advancing the first instrumentfrom a distal end of the first channel to a treatment site within thepatient; advancing the second instrument from a distal end of the secondchannel to the treatment site; and cooperating motion of the distal endsof the first and second instruments, such as by engaging the distal endsof the first and second instruments, one with the other.

[0009] Additionally, the present invention may be used with or adaptedto robotic assisted surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The novel features of the invention are set forth withparticularity in the appended claims. The invention itself, however,both as to organization and methods of operation, together with furtherobjects and advantages thereof, may best be understood by reference tothe following description, taken in conjunction with the accompanyingdrawings in which:

[0011]FIG. 1 is a view showing an end cap and biopsy forceps deviceaccording to an embodiment of the present invention assembled to anendoscope having associated videoscopic and pneumatic equipment.

[0012]FIG. 2 is an isometric view showing the distal end of theendoscope and assembly seen in FIG. 1.

[0013]FIG. 2A is a cross-section view taken through 2A-2A, showing adouble-D hole and a counterbore in a pivot-arm base.

[0014]FIG. 3 is an isometric view of the endoscope and assembly seen inFIG. 1 with the interior flexible member extended and curved throughabout approximately ninety degrees with respect to the endoscope.

[0015]FIG. 4 is an isometric view of the endoscope and assembly seen inFIG. 1 with the interior flexible member extended and curved throughabout approximately ninety degrees with respect to the endoscope and theexterior flexible member extended to cooperate with the interiorflexible member.

[0016]FIG. 5 is an isometric view of the endoscope and assembly seen inFIG. 1 with the interior flexible member extended and curved throughabout approximately one hundred eighty degrees with respect to theendoscope and the exterior flexible member extended to cooperate withthe interior flexible member.

[0017]FIG. 6 is an isometric view of the endoscope and assembly seen inFIG. 1 with the interior flexible member extended and curved throughabout approximately one hundred eighty degrees with respect to theendoscope and the exterior flexible member slightly retracted proximallyfrom the position shown in FIG. 5.

[0018]FIG. 7 is a side view of another embodiment of an end cap having abladed pivot arm utilizing an interior flexible member having suction topull tissue towards the blade.

[0019]FIG. 8 is a side view of the end cap of FIG. 7 with the interiorflexible member retracting to take a biopsy sample.

[0020]FIG. 9 is a side view of the end cap of FIG. 7 with the biopsysample being evacuated away from the work area through the interiorflexible member.

[0021]FIG. 10 is a side view of an embodiment of an end cap cooperatingwith an interior flexible member having a conductive wire through whichRF current may be applied with the flexible member curved through aboutapproximately ninety degrees with respect to the endoscope.

[0022]FIG. 11 is a side view of the end cap and flexible interior memberof FIG. 10 with the flexible interior member curved through aboutapproximately one hundred eighty degrees with respect to the endoscope.

[0023]FIG. 12 is a side view of an embodiment of an end cap with aninterior flexible member carrying a suture and thread and curved throughan angle of about approximately ninety degrees with respect to theendoscope.

[0024]FIG. 13 is a side view of the end cap and interior flexible memberof FIG. 12 with the interior flexible member curved through an angle ofabout approximately one hundred eighty degrees with respect to theendoscope to suture tissue.

[0025]FIG. 14 is a side view of the end cap and interior flexible memberof FIG. 12 with the interior flexible member retracting.

[0026]FIG. 15 is a side view of an end cap and interior flexible memberwith the interior flexible member having an inserted grasper.

[0027]FIG. 16 is a side view of the end cap of FIG. 15 showing thegrasper pulling suture through tissue.

[0028]FIG. 17 is a side view of an embodiment of an end cap and aninterior flexible member equipped to emit ionized argon gas from adistal port.

[0029]FIG. 18 is a side view of an embodiment of an end cap and aninterior flexible member equipped to emit ionized argon gas from acircumferential port.

[0030]FIG. 19 is a side view of an embodiment of an end cap having apivot arm with accordioning extensions.

[0031]FIG. 20 is a side view of the end cap of FIG. 19 showing the pivotarm extended and the interior flexible member rotated through aboutapproximately ninety degrees with respect to the endoscope.

[0032]FIG. 21 is a side view of an embodiment of an end cap having apivot arm with telescoping extensions.

[0033]FIG. 22 is a side view of the end cap of FIG. 21 showing the pivotarm extended and the interior flexible member rotated through aboutapproximately ninety degrees with respect to the endoscope.

[0034]FIG. 23 is a side view showing an embodiment of an end capattached to a grasper inserted through an instrument channel of anendoscope to cooperate with second grasper inserted through a secondinstrument channel of the endoscope.

[0035]FIG. 24 is a side view showing an embodiment of an end capattached to a grasper inserted through an instrument channel of anendoscope to cooperate with second grasper inserted alongside theendoscope.

DETAILED DESCRIPTION OF THE INVENTION

[0036]FIG. 1 depicts a suitable version of an endoscope 14 incombination with one embodiment of the present invention. A suitableversion of endoscope 14 can be the Olympus GIF-P140, and may bepurchased from Olympus America, Inc., in Melville, N.Y.

[0037] A control section 10 is located at the proximal end of endoscope14. A grip section 12 is on control section 10 for grasping of endoscope14. Control section 10 also possesses a right/left angulation controlknob 16 and an up/down angulation control knob 18 for angulating thedistal end of endoscope 14. A right/left angulation lock 20 and anup/down angulation lock 22 are provided to lock their respective knobsinto position. Endoscope 14 may further provide an air/water valve 24and a suction valve 26 attached to control section 10. Remote switches28 extend from control section 10. Remote switches 28 may be used tocontrol auxiliary equipment.

[0038] A boot 30 proceeds distally from control section 10. Aninstrument channel port 32 opens into boot 30 allowing introduction ofinstruments into endoscope 14. The biopsy valve 34 seals instrumentchannel port 32. A narrow, flexible opening within biopsy valve 34allows instruments to pass while providing a gas-tight seal around theinstruments. A valve cap 36 seals biopsy valve 34 when there is noinstrument within the opening of biopsy valve 34.

[0039] The working length 44 extends distally from boot 30. Workinglength 44 can be approximately a meter long, and has flexibility to movethrough body lumens such as the esophagus or lower intestines. Aninstrument channel 42 is open through the entire length of workinglength 44, opening proximally at instrument channel port 32. Fiberoptics for illumination and visualization of the area distal toendoscope 14 also are within working length 44.

[0040]FIG. 1 shows universal cord 104 extending from grip section 12.Universal cord 104 carries fiber optics and a suction tube. A lightsource 106 for illuminating an area distal to the distal end ofendoscope 14 connects to endoscope 14 using fiber optics withinuniversal cord 104. Video monitor 110 connects through fiber opticswithin universal cord 104. Video monitor 110 may be controlled throughan attached video system center 111. Video monitor 110, light source106, and video system center 111 may be operable from remote switches 28and are used to view and photograph areas distal to endoscope 14. Asuction pump 108 is connected as well through universal cord 104 and isused to pull a vacuum through instrument channel 42. Suction pump 108has a collection jar 65 to receive tissue samples that have been pulledthrough instrument channel 42 by suction. Equipment such as suction pump108, light source 106, video monitor 110, and video system center 111may also be purchased through Olympus America, Inc., in Melville, N.Y.

[0041]FIG. 1 further depicts a biopsy forceps device 37 assembled toendoscope 14. Biopsy forceps device 37 has an interior forceps half 50and an exterior forceps half 56. Interior forceps half 50 provides afirst handle 123 with a first plunger 38 at the end of an interiorflexible member 58 to move interior flexible member 58 proximally anddistally. Interior forceps half 50 is inserted into instrument channelport 32 and through instrument channel 42 within endoscope 14. Exteriorforceps half 56 provides a second handle 125 with a second plunger 62 tomove an exterior flexible member 64 proximally and distally. Exteriorforceps half 56 is located alongside endoscope 14 and may be held inplace with attachment bands 40. Exterior flexible member 64 can moveproximally and distally through attachment bands 40.

[0042] Interior flexible member 58 and exterior flexible member 64 eachcan be provided with a junction 67. Each junction 67 may have suctionpump 108 attached to pull a vacuum through interior flexible member 58or exterior flexible member 64 to collection jar 65. Alternatively, eachjunction 67 may have an irrigation water supply attached to provideirrigation water. A plug 73 may be inserted into each junction 67, asshown in FIG. 1, to seal interior flexible member 58 and exteriorflexible member 64 when no external device is attached.

[0043]FIG. 2 depicts the distal end of endoscope 14. Distal face 52 ispositioned at the distal end of endoscope 14 and provides associatedelements for visualization and medical therapy. Instrument channel 42opens at distal face 52 of endoscope 14. Light guide lenses 44, forallowing illumination of the work area, are also shown on distal face 52of endoscope 14. An objective lens 46, placed on distal face 52 ofendoscope 14, receives light from the work area and transmits an imageto video monitor 110 (FIG. 1). An air/water nozzle 48 is located at thedistal end of endoscope 14 adjacent to objective lens 46. Air/waternozzle 48 directs air and water onto objective lens 46 to defog andclean objective lens 46.

[0044] According to the present invention, a device, such as amechanism, can be associated with the distal end of the endoscope 14,the device for guiding a flexible instrument extending from aninstrument channel in the endoscope. As used herein, the term“mechanism” refers to devices having one or more movable members, whichmembers can be relatively rigid or relatively flexible. Such mechanismsinclude, without limitation: simple mechanical devices, such as linkages(e.g. single and multiple link members wherein the links are pivotablyconnected to one another or a base, including four bar linkages, six barlinkages, linkages that include both hinged connections and slidinginterfaces), as well as more complex mechanical devices such astelescoping devices, expanding scissors devices, devices whichincorporate sliding interfaces, ball and socket joints, universaljoints, or other complex connections between members.

[0045] According to one embodiment of the present invention, a pivot-armbase 54 is disposed at the distal end of the endoscope 14, and cansurround the distal end of endoscope 14. Pivot-arm base 54 can bereleasably joined to the distal end of the endoscope 14, such as with alight press fit, threaded engagement, snap fit, or by other suitablemeans. Pivot-arm base 54 can be releasably joined to the distal end ofthe endoscope 14 so that the pivot arm base 54 and its associatedassembly can be removed from the endoscope between operating procedures,such as for cleaning, sterilization, addition of instruments, and thelike. Alternatively, Pivot-arm base 54 can be fixedly attached to thedistal end of the endoscope 14.

[0046] Pivot arm 74 connects to pivot-arm base 54 by, for example, pinsplaced through bosses 55 raised on pivot-arm base 54 and pivot arm 74rotates about pivot axis 71. Pivot-arm stops 139 can be disposed onpivot arm 74 to contact pivot-arm base 54 for limiting the angle throughwhich pivot arm 74 rotates about axis 71. In the embodiment illustratedin FIG. 2, a substantially rigid pivot arm 74 is shown having two curvedsupport halves 77. Each support half 77 of pivot arm 74 extends from aproximal end 77 a adjacent axis 71 to a distal end 77 b. The distal ends77 b can be opposed as shown in FIG. 2. Each support half 77 can beshaped in an arcuate fashion to be curved away from the line of sight ofobjective lens 46 to avoid obstructing the view seen by the physicianthrough objective lens 46. A stepped-diameter pin 75 extends from theunattached distal end 77 b of each support half 77 of pivot arm 74, withthe larger diameter of each stepped-diameter pin 75 nearer support half77 than the smaller diameter. Guide tabs 113 can be located at thedistal ends 77 b of support halves 77 adjacent stepped-diameter pins 75.Guide tabs 113 can include longitudinal ramp surfaces 115 forpositioning mating parts longitudinally, and radial ramp surfaces 117for radially positioning mating parts, as described below.

[0047] Pivot arm 74 together with pivot-arm base 54 are illustrated inthe figures as end cap 82. End cap 82 comprising base 54 and pivot arm74 can be manufactured as a unit for assembly to endoscope 14. End cap82 can be reusable after sterilization, or alternatively, end cap 82could be disposable. End cap 82 can be made from, for example, a plasticsuch as polycarbonate or a metal such as stainless steel. Alternatively,a manufacturer of endoscope 14 could integrate pivot arm 74 withendoscope 14.

[0048] End cap 82, comprising base 54 and pivot arm 74, can be providedin sterile packaging. At the time of the medical procedure, the end cap82 can be removed from the sterile packaging and be joined to the distalend of the endoscope.

[0049]FIG. 2 further shows interior forceps half 50 proceeding frominstrument channel 42. Interior forceps jaw 68 can attach to the end ofinterior flexible member 58 by a press fit into the inner diameter ofinterior flexible member 58. Interior forceps jaw 68 has a first sharpedge 70 and two engagement holes 72 for insertion of the smallerdiameter of stepped-diameter pins 75. Interior forceps jaw 68 andinterior flexible member 58 both have open interior portions, creating ahollow tubular structure through which gas, fluids, particulate matter,or instruments may pass through to the proximal end. Interior flexiblemember 58 may have a spring placed within the structure to support thewalls of interior flexible member 58 while still allowing flexibility.Pivot arm 74 as depicted in FIG. 2 is rigid enough to resist substantialunwanted deflection caused by bending, torsion, and compression loadingapplied by tissue and interior flexible member 58.

[0050]FIG. 2 further depicts pivot arm 74 connecting to interior forcepshalf 50. In the embodiment shown in FIG. 2, pivot arm 74 has twoconnected support halves 77 engaged with stepped-diameter pins 75 tointerior forceps jaw 68, capturing interior forceps jaw 68 to pivot arm74. Stepped-diameter pins 75 align with each other, creating a firstaxis of rotation 119. Interior forceps jaw 68 can rotate freely relativeto pivot arm 74 about first axis of rotation 119, but the rigidity ofpivot arm 74 restricts rotation of interior forceps jaw 68 about thelongitudinal axis of interior forceps jaw 68.

[0051]FIG. 2 also shows the distal end of exterior forceps half 56aligned alongside endoscope 14 and secured by pivot-arm base 54.Exterior forceps half 56 possesses an exterior forceps jaw 76 affixed atthe distal end of exterior flexible member 64. Exterior forceps jaw 76may be attached, for example, by fashioning a connector portion 81 toextend proximally to press-fit into the inner diameter of exteriorflexible member 64. Connector portion 81 has flats 83 on each side toengage a double-D hole 87, depicted in cross-section in FIG. 2A, onpivot-arm base 54. Connector portion 81 can slide linearly throughdouble-D hole 87, but cannot rotate about the longitudinal axis ofexterior forceps jaw 76. Flats 83 on connector portion 81 abut the flatsides of double-D hole 87 to resist such rotation. Exterior forceps jaw76 and exterior flexible member 64 are both open in their interiorportions, creating a tubular structure so that gas, fluids, particulatematter, or instruments may pass through to the proximal end. Exteriorflexible member 64 may also have a spring placed internally for supportof the outer wall.

[0052] Exterior forceps jaw 76 provides a second sharp edge 78 andengagement notches 80. Second sharp edge 78 is used with first sharpedge 70 for tissue cutting, and engagement notches 80 connect with thelarger diameters of stepped-diameter pins 75 to form a biopsy forceps aswill be described. Engagement notches 80 align with each other near thedistal end of exterior forceps jaw 76 to define a second axis ofrotation 121. Interior forceps jaw 68 rotates relative to exteriorforceps jaw 76 about second axis of rotation 121.

[0053]FIG. 3 further shows the distal end of endoscope 14 equipped withend cap 82 and biopsy forceps device 37. In FIG. 3, interior flexiblemember 58 is seen extended and curved through about approximately ninetydegrees. To provide the assembly shown in FIG. 3, a physician or otheruse can first attach end cap 82 to the distal end of endoscope 14.Interior forceps half 50 can be inserted through instrument channel port32 (FIG. 1) and into instrument channel 42. At the distal end ofinstrument channel 42, pivot arm 74 can be connected to interior forcepsjaw 68 by insertion of the smaller diameters of stepped-diameter pins 75into engagement holes 72. Insertion of stepped-diameter pins 75 intoengagement holes 72 may be accomplished, for example, by spreadingsupport halves 77 and positioning engagement holes 72 of interiorforceps jaw 68 in between support halves 77. Support halves 77 may thenbe allowed to return back to their relaxed position to move the smallerdiameters of stepped-diameter pins 75 into engagement holes 72.Alternatively, stepped-diameter pins may be spring loaded, such as inthe fashion of watch band connection pins.

[0054] Exterior forceps half 56 is attached alongside endoscope 14 usingpivot-arm base 54. In the embodiment depicted in FIG. 3, exteriorforceps half 56 slips into double-D hole 87 from the distal side.Exterior flexible member 64, carrying proximally-attached second handle125, press-fits over connector portion 81 to complete the assembly ofexterior forceps half 56. Exterior forceps half 56 may be additionallysecured to endoscope 14 using attachment bands 40. Exterior flexiblemember 64 can be slipped through attachment bands 40.

[0055] Endoscope 14, end cap 82, and biopsy forceps device 37 areinserted into a body near tissue to be examined or treated. The assemblymay be inserted into, for example, a body lumen such as the esophagus orlarge intestine.

[0056] After the device is inserted into the body, first plunger 38(FIG. 1) is depressed extending interior flexible member 58 throughinstrument channel 42. Pivot arm 74 restrains the distal end of interiorflexible member 58 to travel substantially in an arc, curving interiorforceps jaw 68 towards a position distal to distal face 52 of endoscope14 and on the outer periphery of endoscope 14. Pivot arm 74substantially prevents twisting of interior flexible member 58 aroundthe longitudinal axis of interior flexible member 58. Pivot-arm stops139 contact pivot-arm base 54 to prevent over-rotation of pivot arm 74.In the position shown in FIG. 3, interior flexible member 58 andassociated forceps jaw 68 have moved substantially through an arc ofabout approximately ninety degrees. Interior forceps jaw 68 is now in aposition visible through video monitor 110 (FIG. 1) utilizing lightreceived from objective lens 46. The physician may photograph the worksite using photographic equipment available with video system center111. The physician may also use computer equipment to process imagesreceived from the work site. The physician may maneuver interior forcepsjaw 68 to a position to take tissue, such as a polyp, from a biopsysite.

[0057]FIG. 4 shows exterior forceps jaw 76 extending from distalattachment collar 54. Second plunger 62 (FIG. 1) is depressed to moveexterior flexible member 64 and exterior forceps jaw 76 distally. Asexterior forceps jaw 76 extends distally from pivot-arm base 54,longitudinal ramps 115 and radial ramps 117 effectively guide exteriorforceps jaw 76 into position to connect to stepped-diameter pins 75.Engagement notches 80 on exterior forceps jaw 76 engage the largerdiameter of stepped-diameter pins 75, rotatably connecting interiorforceps jaw 68 to exterior forceps jaw 76. The two different diametersof stepped-diameter pins 75 align, so that in the illustrated embodimentfirst axis of rotation 119 and second axis of rotation 121 coincide.First axis of rotation 119 of interior forceps jaw 68 about pivot arm 74and second axis of rotation 121 of interior forceps jaw 68 aboutexterior forceps jaw 76 lie on the same line. Accordingly, jaw 68rotates relative to jaw 76 about the same axis that jaw 68 rotates aboutpivot arm 74.

[0058]FIG. 5 shows interior forceps jaw 68 rotated into a closedposition. First plunger 38 is depressed further to rotate interiorflexible member 58 and associated interior forceps jaw 68 through anadditional ninety degrees to about approximately one hundred eightydegrees of rotation. First sharp edge 70 and second sharp edge 78 canmove past each other and can take a biopsy sample in moving to theillustrated position.

[0059] Because exterior flexible member 64 has an open interior portion,suction pump 108 may be used through a junction open into exteriorforceps half 56 to apply suction through the exterior flexible member64. The biopsy sample or tissue sample can be suctioned away from thebiopsy site. The applied suction can pull a biopsy sample throughexterior flexible member 64 to the proximal end of endoscope 14 and outof endoscope 14. The biopsy sample may be suctioned into collection jar65 and taken for analysis. Alternatively, interior forceps half 50 coulduse collection jar 65 and attached suction pump 108 to collect biopsysamples as well. Suction may be applied from a junction 67 open into theproximal end of interior flexible member 58 to pull a biopsy samplethrough interior flexible member 58. Alternatively, an irrigationsolution such as water could be provided from the proximal end of one ofeither interior forceps half 50 or exterior forceps half 56 to flowthrough the loop created by the closed jaw halves. The flow ofirrigation solution could then force a tissue sample through the otherforceps half for collection.

[0060] These methods enable more than one tissue sample to be takenbefore removing biopsy forceps device 37 from the body. Moving thesample away from the biopsy site, such as by vacuum, frees biopsyforceps device 37 to take another sample.

[0061] Features of pivot arm 74 make it useful for a variety ofapplications. First, pivot arm 74 can be used to constrain motion of thedistal end of interior flexible member 58 to find predictably the sametissue area of interest. This useful attribute enables instrumentsintended to cooperate with interior flexible member 58, such as externalforceps jaw 76, to be repeatably placed at a tissue site that wouldnormally be difficult to repeatably access.

[0062] Second, pivot arm 74 can restrain motion of the distal end ofinterior flexible member 58 along a predetermined path, such as alongarc. In the embodiment shown, the distal end of the flexible member 58can be constrained in translation to cause interior flexible member 58to curve through an arc of 90 degrees or greater to approach tissuespaced from the distal end of the endoscope and associated with theperiphery of endoscope 14 (such as is shown in FIG. 7). In particular,the pivot arm 74 permits positioning of the distal end of the flexiblemember 58 at a tissue site that is adjacent the distal end of theendoscope, yet offset from the longitidunal axis of the endoscope adistance at least as great as the radius of the endoscope. Accordingly,tissue sites adjacent the distal end of the endoscope and associatedwith the perimeter of the endoscope can be accessed in a repeatablefashion.

[0063] Third, as illustrated in FIG. 5, the pivot arm can guide internalflexible member 58 to curve through an arc of about approximately 180degrees to face towards distal face 52 of endoscope 14. Guiding theinternal flexible member 58 to bend through an arc of about 180 degreesallows the distal end of flexible member 58 and any associated medicalinstrument to face the camera or other visualization device associatedwith the distal end of the endoscope. Accordingly, the user can morereadily view various aspects of treatment provided by the flexiblemember 58.

[0064] Fourth, because first axis of rotation 119 coincides with thesecond axis of rotation 121, the need for interior forceps jaw 68 totranslate relative to pivot arm 74 when cooperating with exteriorforceps jaw 76 is eliminated. Cooperative work can be accomplished bysimple rotation of interior forceps jaw 68 once interior forceps jaw 68is joined to exterior forceps jaw 76.

[0065]FIG. 6 illustrates exterior forceps jaw 76 and interior forcepsjaw 68 disengaged. After a biopsy sample has been taken, a physicianmoves second plunger 62 (FIG. 1) proximally to retract exterior flexiblemember 64 and exterior forceps jaw 76 proximally to disengage exteriorforceps jaw 76 from interior forceps jaw 68. The physician also retractsinterior flexible member 58 by moving first plunger 38 (FIG. 1)proximally. Interior flexible member 58 moves through an arc as itretracts into instrument channel 42. Interior flexible member 58, usinginterior forceps jaw 68, rotates pivot arm 74 to return back to theposition parallel to distal face 52 of endoscope 14. The physician maywithdraw endoscope 14 from the patient, or the physician may chooseanother area of tissue within the patient to biopsy. The physician doesnot need to withdraw any portion of biopsy forceps device 37 from thebody before taking another specimen of tissue.

[0066] Different methods of tissue biopsy can be performed on tissueusing end cap 82 attached to an interior flexible member 58. FIG. 7shows an example of a rigid pivot arm 74 equipped with a ring 98containing a blade 100. The embodiment of pivot arm 74 shown in FIG. 7is pivotally attached to pivot-arm base 54. Pivot arm 74 of FIG. 7 isrigid enough to prevent substantial deflection caused by bending,torsion, and compression loading applied by tissue and interior flexiblemember 58. Pivot arm 74 of FIG. 7 could be made of, for example,aluminum or an engineering plastic such as polycarbonate.

[0067]FIG. 7 further illustrates that blade 100 could fit substantiallywithin ring 98 leaving an opening through which a tissue sample couldpass. Interior flexible member 58 assembles to pivot arm 74 using, forexample, a press fit into an extension from ring 98. As illustrated inFIG. 7, interior flexible member 58 could be a tube through whichsuction may be applied. Blade 100 slants proximally towards interiorflexible member 58 to assist in cutting or tearing tissue for biopsy,and blade 100 possesses a knife edge 102.

[0068]FIG. 7 shows an embodiment of interior flexible member 58 attachedto ring 98 of pivot arm 74 and extended to a position adjacent a wall ofbody lumen 88. As shown in FIG. 7, the pivot arm 74 can providerepeatable positioning of the distal end of the flexible member 58 at atissue site that is adjacent the distal end of the endoscope, andradially offset from the longitudinal centerline of the endoscope adistance at least as great as the radius of the endoscope. Accordingly,the mechanism according to the present invention allows repeatableaccess to tissue sites on a body lumen wall adjacent the distal end ofthe endoscope.

[0069] Suction applied to interior flexible member 58 could pull tissuepast blade 100 and into ring 98. Pivot arm 74 can then be retracted, asshown in FIG. 8, by retracting interior flexible member 58 while suctioncontinues through interior flexible member 58. Retraction of pivot arm74 can cause tissue to pull on blade 100 against the proximal slant ofblade 100. Edge 102 of blade 100 can then cut and tear a tissue biopsysample to be retrieved by the suction applied through interior flexiblemember 58, as shown in FIG. 9. If needed, a slight proximal and distalmovement of endoscope 14 can help edge 102 cut and tear tissue to beremoved. Because the tissue sample has been evacuated away from thebiopsy site, another biopsy may then be performed without removinginterior flexible member 58 or endoscope 14 from the body.

[0070] It will be recognized that equivalent structures may besubstituted for the structures illustrated and described herein and thatthe described embodiment of the invention is not the only structurewhich may be employed to implement the claimed invention. As one exampleof an equivalent structure which may be used to implement an embodimentof the present invention, pivot arm 74 may be created from a flexiblestrand such as a suture, wire, or string. FIG. 10 shows two such strandsextending from interior flexible member 58 to connect with pivot-armbase 54 to create an equivalent structure of end cap 82. Tension in thestrands of the embodiment of pivot arm 74 shown in FIG. 10 restrainsinterior flexible member 58 to angulate towards tissue distal to and atthe periphery of endoscope 14. Additionally, because the embodiment ofpivot arm 14 depicted in FIG. 10 consists of two flexible strands undertension, interior flexible member 58 is placed at an apex of atriangular structure. The two strands under tension direct flexiblemember 58 to a specific point along the periphery of endoscope 14.

[0071] Other apparatus may be envisioned to substitute for end cap 82.For example, end cap 82 may comprise a base 54 or an equivalentstructure supporting an equivalent mechanism for pivot arm 74. Forexample, base 54 may become a spring clamp held by spring force toendoscope 14 while carrying a four-bar linkage. The four-bar linkage, byway of further example, can be a substitute mechanism for pivot arm 74to maneuver or guide an instrument. A mechanism such as pivot arm 74 mayattach directly to endoscope 14 without the use of a base or itsequivalent, making the mechanism the entire apparatus for maneuvering orguiding an instrument.

[0072] As a further example of equivalent structures that may be used toimplement the present invention, different end-effectors to performdifferent types of therapy on tissue are seen.

[0073]FIG. 10 and FIG. 11 show pivot arm 74 of end cap 82 attached tointerior flexible member 58 containing a coil spring 84. Interiorflexible member 58 may be transparent to allow visualization of coilspring 84. An opening 86 in the wall of interior flexible member 58exposes a portion of coil spring 84 to a side wall of a body lumen. Coilspring 84 can extend proximally through endoscope 14 to the proximal endwhere an attachment to a generator produces RF current. RF current maybe applied through coil spring 84 to a wall of the body lumen in aspecific area distal to endoscope 14 to cause ablation of tissue fortherapeutic value. Alternatively, two insulated wires could be utilizedto provide bipolar RF current. The wires could end in electrodes placedat opening 86.

[0074]FIGS. 12 through 14 show an example of suturing through the openinterior portion of an extended interior flexible member 58. Interiorflexible member 58 may be formed from a spring with a thin plasticsleeve covering. A needle 92 carrying suture 94 may be used throughinterior flexible member 58. A needle retainer 90 is fashioned at thedistal end of interior flexible member 58. Needle retainer 90 may be,for example, a small tube attached at the distal end of interiorflexible member 58 and having an interior diameter slightly smaller thanneedle 92. Needle 92 is secured within needle retainer 90 by thefriction of a press fit between needle 92 and needle retainer 90. Suture94 trails proximally through interior flexible member 58 to a useful andconvenient length. End cap 82 with pivot arm 74 is attached to thedistal end of endoscope 14.

[0075] A physician can attach suture 94 to needle 92, insert needle 92into needle retainer 90 and extend suture 94 proximally through interiorflexible member 58. End cap 82 is then connected to the distal end ofendoscope 14, and pivot arm 74 joined with the distal end of interiorflexible member 58. Interior flexible member 58 extends and travelsthrough an arc while restrained at the distal end of pivot arm 74,carrying needle 92 to pierce the wall of body lumen 88 at a precisepoint. Needle 92 may be fashioned with a curvature designed to travelthrough the tissue of body lumen 88 and emerge at a point offset fromthe insertion point in a manner shown in FIGS. 12 through 14. Afterneedle 92 has looped through tissue, interior flexible member 58 can bewithdrawn to leave needle 92 within the tissue to the side of the lumen.

[0076]FIGS. 15 and 16 depict grasper 96 emerging from interior flexiblemember 58. A suitable grasper 96 may be purchased from MicrovasiveEndoscopy, in Quincy, Mass. A physician may take grasper 96 and insertit through interior flexible member 58, grasp the end of needle 92, andpull suture through the opening created by the needle. To tie off theknot, a physician may place a clip on the loose threads to secure thesuture.

[0077]FIG. 17 shows an embodiment of a mechanism maneuvering an interiorflexible member 58 that can emit ionized argon gas 101 to facilitate theflow of electrical current. A distal opening 99 to emit ionized gas maybe at the distal end of flexible member 58 as shown in FIG. 17, or acircumferential opening 103 may be placed on a circumferential portionof flexible member 58 as shown in FIG. 18. Ionized argon gas 101 cancoagulate large areas of tissue in a non-contact technique. Afterendoscope 14 is advanced into a body lumen such as the esophagus, pivotarm 74 can bend interior flexible member 58 to a point near, but nottouching, the inner surface of the body lumen. A sufficient voltage isthen placed across electrodes to ionize argon gas 101 proceeding fromflexible member 58. In the embodiments shown in FIG. 17 and FIG. 18,interior flexible member 58 is lined with a conductive spring 61 toserve as an electrode. A return electrode is also supplied. For example,base 54 can be made of a conductive material to serve as a returnelectrode.

[0078] As a further example of an equivalent structure that may be usedto implement the present invention, a rigid pivot arm 74 may haveextensions to permit more distal movement of interior flexible member58.

[0079]FIG. 19 shows an embodiment of pivot arm 74 with rotatingextensions 127 rotatably pinned to accommodate a design of pivot arm 74that will accordion as interior flexible member 58 is moved distally.FIG. 20 shows the design of FIG. 19 in an extended position.

[0080]FIG. 21 shows a design of pivot arm 74 that has telescopingextensions 129. FIG. 22 shows the design of FIG. 21 in an extendedposition.

[0081] It will become readily apparent that many other instruments maybe created to take advantage of configurations of pivot arm 74. Theseinstruments may, for example, provide injection therapy, irrigate theworksite, resect mucosa, and perform other useful functions fortreatment of body tissue. Interior forceps jaw 68 or exterior forcepsjaw 76 may become any interior end-effector or external end-effector forperforming useful work. Internal flexible member 58 and externalflexible member 64 may be any flexible members capable of maneuvering anend-effector, and each may have a handle for maneuvering and actuatingits respective end-effector. A first instrument having a first handle,an internal flexible member and an internal end-effector may then beinserted through instrument channel 42 of endoscope 14 and connected toan embodiment of pivot arm 74. A second instrument may be created havinga second handle, an external flexible member, and an externalend-effector. The first instrument may then be used cooperatively withthe second instrument inserted alongside endoscope 14 or through asecond instrument channel within endoscope 14 to perform therapy. It ispossible for instruments to be linked to become one instrument with twoend-effectors. The instrument created by linking may have one handlewith one actuation mechanism to activate both end-effectors.

[0082]FIG. 23 shows a first grasper 131 inserted through a firstinstrument channel 133 of a multi-channeled endoscope 141 having atleast two instrument channels. First grasper 131 is connected to anembodiment of pivot arm 74. First grasper 131 can cooperate with asecond grasper 135 inserted through a second instrument channel 137 toperform work on tissue distal to and on the periphery of multi-channeledendoscope 141.

[0083]FIG. 24 shows a first grasper 131 inserted through an instrumentchannel 42 of an endoscope 14. First grasper 131 is connected to anembodiment of pivot arm 74. First grasper 131 can cooperate with asecond grasper 135 inserted alongside endoscope 14. Additionalinstruments may also be inserted to cooperate with first grasper 131.

[0084] The embodiments shown illustrate the use of the invention inconnection with an endoscope within a body lumen. However, the inventionis not limited to use within a naturally occuring body lumen, but isalso useful in a variety of minimally invasive medical procedures,including without limitation medical procedures performed throughlaparoscopic incisions for access to body cavities and internal organsof the body. The invention also encompasses apparatus and methodsemploying endoscopic devices in general, including various forms andvariations of endoscopes, including without limitation: laparascopes,gastroscopes, peritoneoscopes, sigmoidoscopes, fiberoptic endoscopes,and the like.

[0085] The embodiments shown illustrate the use of the invention inconnection with an endoscope within a body lumen. However, the inventionis not limited to use within a naturally occuring body lumen, but isalso useful in a variety of minimally invasive medical procedures,including without limitation medical procedures performed throughlaparoscopic incisions for access to body cavities and internal organsof the body. The invention also encompasses apparatus and methodsemploying endoscopic devices in general, including various forms andvariations of endoscopes, including without limitation: laparascopes,gastroscopes, peritoneoscopes, sigmoidoscopes, fiberoptic endoscopes,and the like.

[0086] While preferred embodiments of the present invention have beenshown and described herein, it will be obvious to those skilled in theart that such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. For example, as wouldbe apparent to those skilled in the art, the disclosures herein haveequal application in robotic-assisted surgery. In addition, it should beunderstood that every structure described above has a function and suchstructure can be referred to as a means for performing that function.Numerous variations, changes, and substitutions will now occur to thoseskilled in the art without departing from the invention. Accordingly, itis intended that the invention be limited only by the spirit and scopeof the appended claims.

What is claimed is:
 1. A method of treating tissue within a patient,said method comprising the steps of: providing at least one instrumenthaving a distal end; providing at least one channel for accessing atreatment site; extending at least a portion of the instrument from adistal end of the channel to access the treatment site; and guidingmotion of the distal end of instrument at the treatment site.
 2. Themethod of claim 1 wherein the step of guiding motion of the distal endof the instrument comprises restricting twisting of the instrument aboutthe longitudinal axis of the instrument.
 3. The method of claim 1wherein the step of guiding motion of the end of the instrumentcomprises bending the instrument.
 4. The method of claim 3 wherein thestep of bending the instrument comprises bending the instrument throughan angle of at least about 90 degrees.
 5. The method of claim 1 whereinthe step of guiding motion of the end of the instrument comprisesconstraining motion of the distal end of the instrument along apredetermined path, wherein the path is not parallel to a longitudinalaxis of the channel.
 6. The method of claim 1 wherein the step ofguiding motion of the end of the instrument comprises constrainingmotion of the end of the instrument along an arc.
 7. The method of claim1 wherein the step of providing at least one channel comprises providinga channel having a proximal channel opening outside the patient and adistal channel opening within the patient.
 8. The method of claim 1wherein the step of guiding motion of the end of the instrumentcomprises bending the instrument to position the end of the instrumentadjacent a lumen wall.
 9. The method of claim 1 further comprising thestep of cutting a tissue sample.
 10. The method of claim 9 furthercomprising the step of removing the tissue sample through the channelwithout removing the instrument from the channel.
 11. The method ofclaim 1 further comprising the step of ablating tissue.
 12. The methodof claim 1 further comprising the step of treating the tissue with argonplasma.
 13. The method of claim 1 wherein the first instrument comprisesa hollow member, and wherein the method further comprises communicatinga source of vacuum with the hollow member.
 14. A method of treatingtissue within a patient, said method comprising the steps of: providinga first instrument having a distal end; providing a second instrumenthaving a distal end; providing a first channel for accessing a treatmentsite; providing a second channel for accessing a treatment site;advancing the first instrument from a distal end of the first channel toa treatment site within the patient; advancing the second instrumentfrom a distal end of the second channel to the treatment site; andcooperating motion of the distal ends of the first and secondinstruments.
 15. The method of claim 14 wherein the step of cooperatingmotion of the distal ends of the first and second instruments comprisesengaging the distal ends of the first and second instruments, one withthe other.
 16. The method of claim 14 wherein the step of cooperatingmotion of the distal ends of the first and second instruments comprisesbending at least one of the first and second instruments.
 17. The methodof claim 14 wherein the step of cooperating motion of the distal ends ofthe first and second instruments comprises preventing twisting of atleast one of the first and second instruments.
 18. The method of claim14 wherein the step of cooperating motion of the distal ends of thefirst and second instruments comprises bending at least one of the firstand second instrument through an angle of at least about 90 degrees. 19.The method of claim 18 wherein the step of cooperating motion of thedistal ends of the first and second instruments comprises bending atleast one of the first and second instruments through an angle of atleast about 180 degrees.
 20. A method of treating tissue within apatient, said method comprising the steps of: providing an endoscopehaving at least one instrument channel; disposing the endoscope in abody lumen; advancing a flexible instrument from the distal end of theinstrument channel to access a treatment site in the body lumen; andguiding motion of the distal end of the flexible instrument as theinstrument is advanced from the distal end of the instrument channel.21. The method of claim 20 wherein the step of guiding motion of the endof the flexible instrument comprises bending the instrument as theinstrument is advanced from the instrument channel.
 22. The method ofclaim 20 wherein the step of bending the instrument comprises bendingthe instrument through an angle of at least about 90 degrees.
 23. Themethod of claim 22 wherein the step of bending the instrument comprisesbending the instrument through an angle of at least about 180 degrees.24. The method of claim 20 wherein the step of guiding motion of the endof the instrument comprises constraining motion of the distal end of theinstrument along a desired path.
 25. The method of claim 20 wherein thestep of guiding motion of the end of the instrument comprisesconstraining motion of the end of the instrument along an arc.
 26. Themethod of claim 20 wherein the step of guiding motion of the end of theinstrument comprises positioning the distal end of the instrumentadjacent a lumen wall.
 27. The method of claim 20 wherein the step ofguiding motion of the end of the instrument comprises positioning thedistal end of the instrument to treat tissue located adjacent theperimeter of the distal end of endoscope.
 28. The method of claim 20wherein the step of guiding motion of the end of the instrumentcomprises providing a device disposed at the distal end of the endoscopefor constraining motion of the distal end of the instrument a long adesired path.
 29. A method of treating tissue within a patient, saidmethod comprising: attaching a mechanism for guiding motion of a medicalinstrument to the distal end of an endoscope; inserting a firstinstrument having a distal end through an instrument channel of saidendoscope; connecting the distal end of the medical instrument to themechansim; inserting said endoscope with the mechanism and the medicalinstrument into the patient.
 30. The method of claim 20 furthercomprising the step of suturing tissue.